Northwest Cosmetic Labs on the Forefront of New FDA Sunscreen Regulations

Decoding the language so your quality products will comply.

On June 14, 2011 the FDA announced updated testing and labeling standards, known as the sunscreen monograph, for non-prescription sunscreen products currently sold in the United States. Local skin care and cosmetic product manufacturer, Northwest Cosmetic Labs, a Gary Voigt owned company, is poised to lead your company in compliance with the U.S. Food & Drug Administration guidelines.

According to the FDA, these requirements include “significant changes to sunscreen products that will help consumers decide how to buy and use sunscreen, and allow them to more effectively protect themselves and their families from sun-induced damage.”

One of these changes is the addition of the ‘broad spectrum’ classification.  According to the new FDA guidelines, sunscreens that are classified as broad spectrum and have SPF values of 15 or higher may state that they “reduce the risk of skin cancer and early skin aging, when used as directed.” Sunscreen products that have SPF values between 2 and 14 may be labeled as broad spectrum, but only if they pass the required testing. Wendy Lees, NCL Director of Quality Assurance and Regulatory Compliance, explains, “Prior to this new monograph, labeling of sunscreen only gave the consumer the overall SPF rating (protection against UV rays).  The new ‘broad spectrum’ labeling, provides more information to the consumer on the protection the product will provide against UVA as well.”

Additionally, a product that is not classified as Broad Spectrum, or one that is Broad Spectrum but has an SPF between 2 to 14, will be required to have a warning stating that the product has “not been shown to help prevent skin cancer or early skin aging.”

In addition to the changes to the labeling guidelines, the FDA released three additional documents outlining changes to the way sunscreen SPF can be labeled.  For example, no longer can sunscreen products be labeled as having an SPF higher than 50.  This is due to insufficient data showing that products with SPF values higher than that can provide greater protection for users than products with SPF values of 50. The rule does allow research bodies to provide future data that would support the inclusion of SPF 50+ products. 

The additional documents also address the effectiveness and safety of sunscreen sprays, including possible changes that the FDA may pursue concerning usage directions and warnings for these sprays.

The last of these documents establishes industry standards for sunscreen product manufacturers, like Northwest Cosmetic Labs, who are testing these sunscreen products and gives guidance in the process to comply with the new regulations.  Most cosmetic manufacturers have one year to comply.

These requirements support the FDA’s efforts to ensure that all over-the-counter sunscreens meet modern-day standards for safety and effectiveness and reflect the latest scientific research. Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, as quoted on industry website happi (Household and Personal Products Industry) states,  "These changes to sunscreen labels are an important part of helping consumers have the information they need so they can choose the right sun protection for themselves and their families."

Northwest Cosmetic Labs is currently working with their clients to meet the one-year deadline to comply with these FDA standards. Lees explains, “We are providing assistance on what changes will need to be made to existing product labels and also specify any testing that may be need to be performed for…products to be in compliance with the new monograph.”

Please contact us today so that we can outline a plan to ensure your quality sunscreen products comply with these important new standards for sun safety.